Equipment Validation Associate

Location: Hunt Valley

Job Overview:

Responsible for assuring the highest quality level of the company processes and products maintaining monitoring of qualifications and validation of facilities, instruments, and equipment, performing, and supporting cleaning and process validation, ensuring proper performance as per company procedures, and providing excellent service to guarantee customer satisfaction. Support validation activities for aseptic and non-aseptic production environment.

Focus of position:
Calibration/Metrology/Equipment Qualification

Manages, coordinates, performs, and reports all activities related to the calibration of equipment used at Pharmaceutics International Incorporated. Support other validation activities such as equipment commissioning, qualifications, and process validations.

Responsibilities:

The essential functions of the position include, but are not limited to:

Performs calibrations for all equipment and instrumentation involved in, but not limited to, manufacturing processes at Pharmaceutics International Incorporated.

Understands equipment/instrument specifications, calibrations, out of specifications, tolerance limits for different instruments

Creates documentation that accurately describes the procedures required to effectively calibrate equipment.

Provides initial Standard Operating Procedure (SOP) training to all responsible personnel.

Assists in the troubleshooting of equipment and contacts maintenance for all repairs when necessary.

Review equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packaging, and cleaning validations prepared by other team members.

Assures that assigned obligations are conducted in accordance with cGMPs, or any other company approved documentation.

Interacts with peers and vendors to ensure project timelines are achieved and offering satisfactory alternatives when necessary.

Execute protocols and related activities associated with cleaning and process validation, transferring new products/ processes from R&D to manufacturing, and executing process/documentation improvements. Perform statistical analysis for process monitoring.

Initiate and investigate protocol deviations, events, exceptions, and coordinate follow up with QA. Initiate, follow-up, close out and implementation of corrective and preventive actions.

Co-ordinate activities related to risk management and preparation of quality risk management and risk assessments related to products and processes.

Coordinate with cross functional teams for internal and external audits. Provide all required documentation. Interacts with other departments to ensure project activities are performed in a timely manner.

Scans, archives, and organizes all validation documentation.

Continues to increase knowledge of latest process technologies within the pharmaceutical industry.

Additional functions and responsibilities as needed or assigned.

Essential Specialized Knowledge and/or Skills to Perform Job:

Ability to read, write and speak English fluently.

Ability to communicate effectively to team members on a routine basis

Knowledge of cGMPs, manufacturing procedures of Pii's product line and company policies/regulations; knowledge of manufacturing operations and validation guidelines - SOPs, FDA, OSHA, DEA and MSDS requirements.

Qualifications:

Education/Experience: Bachelor's degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities. Associate with a minimum of 2 years experience within the pharmaceutical, cosmetic, or food industry, specifically with Metrology/Calibrations.

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

Analytical - Working knowledge of cGMPs and internal SOPs; identifies, collects and organizes data from multiple sources; ability to handle several projects simultaneously; demonstrates attention to detail; identifies and resolves problems in a timely manner.

Customer Service - Responds to requests for service and assistance with professionalism, courtesy and confidence.

Technical Skills - Ability to make timely decisions, root cause analysis and ability to define effective corrective and preventative action.

Interpersonal Skills - Interacts with management and non-management employees across all department within Pii and outside clients.

Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarifications.

Team Work - Balances team and individual responsibilities; able to build morale and group commitments to goals and objectives; focuses on solving conflict, not blaming; maintains confidentiality; listens to others without interrupting; remains open to others ideas and not afraid to try new ideas.

Diversity - Shows respect and sensitivity for personal and cultural differences. Values multiple viewpoints and is sensitive to factors (race, gender, age, culture, and religion) that may affect…